Creative Biogene offers a broad range of high-quality testing service for cell line characterization and virus bank characterization during the manufacturing process. Based on well-established platforms and expertise, our experienced scientist team is committed to meeting different testing requirements with trusted and accurate results. All testing services undergo by a strict quality control and quality assurance in accordance to the guideline of government agencies.
Cell bank and virus bank, which are the foundation of manufacturing biological products, are crucial for the quality of products. Some quality concerns for cell-derived/virus-derived biological products have originated from the properties of the cells/viruses used to prepare the product or from the presence of adventitious contaminants. Thus, it is essential to have a characterization test before using the cell line and virus bank. The routine characterization test contains test of identity, purity, stability and virus potency/cell tumorigenicity.
Creative Biogene provides a professional characterization testing service for cell line and virus bank. We offer international testing methodologies, while customized method development is also available. Creative Biogene offers characterization service including:
Cell Line Characterization
Virus Bank Characterization
For more information, please contact us at any time.
1. ICH Topic Q 5 D Quality of Biotechnological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products.
2. ICH Topic Q 5 A Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.